Analytical Evaluation of Visby Medical RT-PCR Portable Device for Rapid Detection of SARS-CoV-2
Extended community testing constitutes one of the main strategic pillars in controlling the COVID-19 pandemic. Reverse transcription PCR (RT-PCR) targeting the SARS-CoV-2 genome on nasopharyngeal swab samples is currently the reference test. While displaying excellent analytical sensitivity and spec...
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| Format: | Article |
| Language: | English |
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MDPI AG
2021-04-01
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| Series: | Diagnostics |
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| Online Access: | https://www.mdpi.com/2075-4418/11/5/813 |
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| author | Adriana Renzoni Francisco Perez Marie Thérèse Ngo Nsoga Sabine Yerly Erik Boehm Angèle Gayet-Ageron Laurent Kaiser Manuel Schibler |
| author_facet | Adriana Renzoni Francisco Perez Marie Thérèse Ngo Nsoga Sabine Yerly Erik Boehm Angèle Gayet-Ageron Laurent Kaiser Manuel Schibler |
| author_sort | Adriana Renzoni |
| collection | DOAJ |
| description | Extended community testing constitutes one of the main strategic pillars in controlling the COVID-19 pandemic. Reverse transcription PCR (RT-PCR) targeting the SARS-CoV-2 genome on nasopharyngeal swab samples is currently the reference test. While displaying excellent analytical sensitivity and specificity, this test is costly, often requires a substantial turnaround time, and, more importantly, is subject to reagent and other material shortages. To complement this technology, rapid antigen tests have been developed and made available worldwide, allowing cheap, quick, and decentralized SARS-CoV-2 testing. The main drawback of these tests is the reduced sensitivity when RT-PCR is the gold standard. In this study, we evaluate Visby an innovative, portable, easy-to-use RT-PCR point-of-care (POC) diagnostic device. Our retrospective analysis shows that overall, compared to the Cobas 6800 RT-qPCR assay (Roche), this RT-PCR POC technology detects SARS-CoV-2 RNA with 95% sensitivity (95%CI = 86.3–99%) and 100% specificity (95% CI = 80.5–100%). For samples with cycle-threshold values below 31, we observed 100% sensitivity (95% CI = 66.4–100%). While showing an analytical sensitivity slightly below that of a standard RT-qPCR system, the evaluated Visby RT-PCR POC device may prove to be an interesting diagnostic alternative in the COVID-19 pandemic, potentially combining the practical advantages of rapid antigen tests and the robust analytical performances of nucleic acid detection systems. |
| first_indexed | 2024-03-10T11:49:30Z |
| format | Article |
| id | doaj.art-b98aead9318742988a58790d3f3b9c77 |
| institution | Directory Open Access Journal |
| issn | 2075-4418 |
| language | English |
| last_indexed | 2024-03-10T11:49:30Z |
| publishDate | 2021-04-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Diagnostics |
| spelling | doaj.art-b98aead9318742988a58790d3f3b9c772023-11-21T17:51:55ZengMDPI AGDiagnostics2075-44182021-04-0111581310.3390/diagnostics11050813Analytical Evaluation of Visby Medical RT-PCR Portable Device for Rapid Detection of SARS-CoV-2Adriana Renzoni0Francisco Perez1Marie Thérèse Ngo Nsoga2Sabine Yerly3Erik Boehm4Angèle Gayet-Ageron5Laurent Kaiser6Manuel Schibler7Laboratory of Virology, Laboratory Medicine Division, Diagnostic Department, Geneva University Hospitals, CH-1211 Geneva, SwitzerlandFaculty of Medicine of Geneva, University of Geneva, CH-1211 Geneva, SwitzerlandFaculty of Medicine of Geneva, University of Geneva, CH-1211 Geneva, SwitzerlandLaboratory of Virology, Laboratory Medicine Division, Diagnostic Department, Geneva University Hospitals, CH-1211 Geneva, SwitzerlandLaboratory of Virology, Laboratory Medicine Division, Diagnostic Department, Geneva University Hospitals, CH-1211 Geneva, SwitzerlandCRC & Division of Clinical-Epidemiology, Department of Health and Community Medicine, University of Geneva & University Hospitals of Geneva, CH-1211 Geneva, SwitzerlandLaboratory of Virology, Laboratory Medicine Division, Diagnostic Department, Geneva University Hospitals, CH-1211 Geneva, SwitzerlandLaboratory of Virology, Laboratory Medicine Division, Diagnostic Department, Geneva University Hospitals, CH-1211 Geneva, SwitzerlandExtended community testing constitutes one of the main strategic pillars in controlling the COVID-19 pandemic. Reverse transcription PCR (RT-PCR) targeting the SARS-CoV-2 genome on nasopharyngeal swab samples is currently the reference test. While displaying excellent analytical sensitivity and specificity, this test is costly, often requires a substantial turnaround time, and, more importantly, is subject to reagent and other material shortages. To complement this technology, rapid antigen tests have been developed and made available worldwide, allowing cheap, quick, and decentralized SARS-CoV-2 testing. The main drawback of these tests is the reduced sensitivity when RT-PCR is the gold standard. In this study, we evaluate Visby an innovative, portable, easy-to-use RT-PCR point-of-care (POC) diagnostic device. Our retrospective analysis shows that overall, compared to the Cobas 6800 RT-qPCR assay (Roche), this RT-PCR POC technology detects SARS-CoV-2 RNA with 95% sensitivity (95%CI = 86.3–99%) and 100% specificity (95% CI = 80.5–100%). For samples with cycle-threshold values below 31, we observed 100% sensitivity (95% CI = 66.4–100%). While showing an analytical sensitivity slightly below that of a standard RT-qPCR system, the evaluated Visby RT-PCR POC device may prove to be an interesting diagnostic alternative in the COVID-19 pandemic, potentially combining the practical advantages of rapid antigen tests and the robust analytical performances of nucleic acid detection systems.https://www.mdpi.com/2075-4418/11/5/813SARS-CoV-2rapid diagnostic techniquesPOCT techniques |
| spellingShingle | Adriana Renzoni Francisco Perez Marie Thérèse Ngo Nsoga Sabine Yerly Erik Boehm Angèle Gayet-Ageron Laurent Kaiser Manuel Schibler Analytical Evaluation of Visby Medical RT-PCR Portable Device for Rapid Detection of SARS-CoV-2 Diagnostics SARS-CoV-2 rapid diagnostic techniques POCT techniques |
| title | Analytical Evaluation of Visby Medical RT-PCR Portable Device for Rapid Detection of SARS-CoV-2 |
| title_full | Analytical Evaluation of Visby Medical RT-PCR Portable Device for Rapid Detection of SARS-CoV-2 |
| title_fullStr | Analytical Evaluation of Visby Medical RT-PCR Portable Device for Rapid Detection of SARS-CoV-2 |
| title_full_unstemmed | Analytical Evaluation of Visby Medical RT-PCR Portable Device for Rapid Detection of SARS-CoV-2 |
| title_short | Analytical Evaluation of Visby Medical RT-PCR Portable Device for Rapid Detection of SARS-CoV-2 |
| title_sort | analytical evaluation of visby medical rt pcr portable device for rapid detection of sars cov 2 |
| topic | SARS-CoV-2 rapid diagnostic techniques POCT techniques |
| url | https://www.mdpi.com/2075-4418/11/5/813 |
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